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Study of Biostate® in Children With Hemophilia A

NCT01229007 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-08-24

No results posted yet for this study

Summary

The objective of this study is to assess the efficacy and safety of a Von Willebrand Factor/Factor VIII (VWF/FVIII), Biostate, and to investigate the pharmacokinetics of Biostate in children with haemophilia A.

Conditions

Interventions

BIOLOGICAL

Biostate

1 dose of 50 IU FVIII/kg body weight of Biostate administered intravenously on Day 1 in the PK component, followed by the Efficacy component for continuation of Biostate therapy, as required for a minimum of 50 exposure days.

Sponsors & Collaborators

  • Parexel

    collaborator INDUSTRY

  • CSL Behring

    lead INDUSTRY

Principal Investigators

  • Program Director Clinical R&D · CSL Behring

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
12 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2014-07-31
Completion
2014-07-31

Countries

  • Belarus
  • Georgia
  • Guatemala
  • Lebanon
  • Mexico
  • Ukraine

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01229007 on ClinicalTrials.gov